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Table 3 Criteria for holding and stopping IL2 #

From: High dose interleukin-2 (Aldesleukin) - expert consensus on best management practices-2014

System

Relative criteria

Absolute criteria

Cardiovascular

Sinus tachycardia 100-130 BPM*

Sinus tachycardia > 130 BPM*

ECG indications of ischemia

Atrial fibrillation

Supraventricular tachycardia

Ventricular arrhythmias**

Elevated CKB-MB isoenzyme of troponin levels

Dermatologic

Moist desquamation

 

Gastrointestinal

Diarrhea, 1000 ml/shift

Diarrhea 1000 ml/shift x 2

Vomiting not responsive to medication

Ileus/abdominal distention

Severe abdominal distention affecting breathing

Bilirubin > 7 mg/dL

Severe, unrelenting abdominal pain

Hemodynamic#*

Maximum Phenylephrine 1-1.5 mcg/kg/min

Maximum Phenylephrine 1.5-2.0 mcg/kg/min

Minimum Phenylephrine > 0.5 mcg/kg/min

Minimum Phenylephrine > 0.8 mcg/kg/min

Hemorrhagic

Sputum, emesis, or stool heme-positive

Frank blood in sputum, emesis, or stool

Platelets 30,000-50,000/mm3

Platelets < 30,000 mm3

Infectious

 

Strong clinical suspicion or documented

Musculoskeletal

Weight gain > 15%

 

Extreme tightness

Extreme paresthesias

Neurologic

Vivid dreams

Hallucinations

Mild anxiety

Persistent crying

Mental status changes not reversible in 2 hours

Unable to subtract serial "7 s" or spell "WORLD" backward

Disorientation

Pulmonary

Resting shortness of breath

> 4 L O2 by nasal cannula or 40% by mask to maintain ≥ 95% O2 saturation

3- 4 L O2 by nasal cannula for O2 saturation ≥ 95%

Intubation

Rales 1/3 up chest

Moist rales ½ up chest

Renal

Urine output 80-160 ml/shift

Urine < 80 ml/shift

Creatinine 2.5-2.9 mg/dL

Creatinine ≥ 3 mg/dL

HCO3 ≤ 18 meq/dL

  1. Abbreviations: BPM, beats per minute; ECG, electrocardiogram.
  2. *Persistent at the time of dosing after correcting hypotension, fever, and tachycardia and discontinuing dopamine.
  3. **Including premature ventricular contractions, bigeminy, and tachycardia.
  4. #In order to maintain acceptable BP and pulse criteria.
  5. *Phenylephrine Max is during the interval, Min at the time of dosing.
  6. #The above criteria should be assessed at the scheduled time of next dose after aggressive measures to correct toxicity have been undertaken.
  7. If ≤ 3 relative criteria, delay dosing, continue corrective measures and administer another dose if recovered in < 24 hours.
  8. If >3 relative criteria or an absolute criteria are observed stop IL-2 for the current cycle.
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